ENVARSUS XR can cause serious side effects, including:
Increased risk of cancer. People who take ENVARSUS XR have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
Increased risk of infection. ENVARSUS XR is a medicine that affects your immune system. ENVARSUS XR can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving ENVARSUS XR.

How to take ENVARSUS XR

How ENVARSUS XR is different

ENVARSUS XR is not the same as tacrolimus capsules that must be taken twice a day (Prograf® or generic tacrolimus)—and it is not the same as another once-daily tacrolimus product called Astagraf XL®, which is a capsule, not a tablet.

Other brands of tacrolimus or generic tacrolimus cannot be mixed with ENVARSUS XR. There is no generic substitute for ENVARSUS XR, and the dosing is different from other tacrolimus products. If you are prescribed ENVARSUS XR, be sure it is the only tacrolimus medicine you are taking.

Other tacrolimus products (such as Prograf®) you may be familiar with are taken twice a day. Do not take ENVARSUS XR more than once a day. ENVARSUS XR extended-release tablets were designed to work with just one dose all day (24 hours) for kidney transplant patients!

DO NOT take any other tacrolimus capsules while you are on ENVARSUS XR.

Your total daily dose of ENVARSUS XR may be lower than the total daily dose you were taking of another tacrolimus product. DO NOT change your dose of ENVARSUS XR unless your doctor tells you to do so.

Take ENVARSUS XR tablets just once a day

Take your first dose of ENVARSUS XR the morning after you take your last evening dose of your current tacrolimus product.

Take once-daily ENVARSUS XR tablets with fluid (preferably with water) on an empty stomach at the same time each day (preferably in the morning). This helps to keep enough medicine in your body to give your transplanted organ the around-the-clock medicine it needs. Be sure to decide with your transplant team the best time of day to take your medicine, so that they will know what time of day to schedule your blood tests.

If you miss your dose of ENVARSUS XR, it should be taken as soon as possible, but no longer than 15 hours after the scheduled time. If the missed dose is not noticed until more than 15 hours later, it should be skipped and the next dose should be taken the following morning at your regularly scheduled time. Do not take 2 doses at the same time. Also, if you miss your dose of ENVARSUS XR, call your transplant coordinator as soon as possible.

If you take too much ENVARSUS XR, call your doctor or go to the nearest hospital emergency room right away.

You should not eat grapefruit or drink grapefruit juice while taking ENVARSUS XR.

You should not drink alcohol while taking ENVARSUS XR.

Tell your doctor if you have any side effects that bother you or that do not go away. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

To report side effects, contact Veloxis Pharmaceuticals, Inc. at 1-844-VELOXIS (835-6947) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Be sure your tablet is ENVARSUS XR

Be sure your ENVARSUS XR tablet looks like the one in the picture and has the correct dosage strength number on one side of the tablet, and TCS on the back side. The dosage strength number on the tablet should match what's on your pill bottle.

Dose Side

0.75 mg Tablet

1 mg Tablet

4 mg Tablet

Back Side

0.75 mg Tablet

1 mg Tablet

4 mg Tablet

Tablets shown are not actual size.

Your pill bottle from the pharmacy must always say ENVARSUS XR. If any of these things do not match, call your pharmacist, doctor,and/or transplant coordinator right away.

What is the most important information I should know about ENVARSUS XR?

ENVARSUS XR can cause serious side effects, including:

Increased risk of cancer. People who take ENVARSUS XR have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).

Increased risk of infection. ENVARSUS XR is a medicine that affects your immune system. ENVARSUS XR can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving ENVARSUS XR that can cause death.

Call your doctor right away if you have symptoms of an infection such as:

fever

cough or flu-like symptoms

warm, red, or painful areas on your skin

sweats or chills

muscle aches

What is ENVARSUS XR?

ENVARSUS XR is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney transplant.

ENVARSUS XR is an extended-release tablet and is not the same as tacrolimus extended-release capsules or tacrolimus immediate-release capsules. Your doctor should decide what medicine is right for you.

Who should not take ENVARSUS XR?

Do not take ENVARSUS XR if you are allergic to tacrolimus or any of the ingredients in ENVARSUS XR. See the end of this leaflet for a complete list of ingredients in ENVARSUS XR.

What should I tell my doctor before taking ENVARSUS XR?

Before you take ENVARSUS XR, tell your doctor if you:

plan to receive any live vaccines. Ask your doctor if you are not sure if your vaccine is a live vaccine.

have or have had liver, kidney or heart problems.

have any other medical conditions.

are pregnant or plan to become pregnant. ENVARSUS XR may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

are breastfeeding or plan to breastfeed. ENVARSUS XR can pass into your breast milk. You and your doctor should decide if you will take ENVARSUS XR or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ENVARSUS XR may affect the way other medicines work, and other medicines may affect how ENVARSUS XR works.

How should I take ENVARSUS XR?

Take ENVARSUS XR exactly as your doctor tells you to take it.

Your doctor may change your dose of ENVARSUS XR if needed. Do not stop taking or change your dose of ENVARSUS XR without talking to your doctor.

Take ENVARSUS XR once daily with fluid (preferably water) on an empty stomach at the same time each day (preferably in the morning).

If you miss your dose of ENVARSUS XR, it should be taken as soon as possible, but no longer than 15 hours after missing your dose. If the time after you miss your dose is more than 15 hours, the missed dose should be skipped and the next dose should be taken the following morning at your regularly scheduled time. Do not take 2 doses at the same time.

If you take too much ENVARSUS XR, call your doctor or go to the nearest hospital emergency room right away.

Exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.

You should not eat grapefruit or drink grapefruit juice while taking ENVARSUS XR.

You should not drink alcohol while taking ENVARSUS XR.

What are the possible side effects of ENVARSUS XR?

ENVARSUS XR may cause serious side effects, including:

See “What is the most important information I should know about ENVARSUS XR?”

Graft rejection and other serious reactions. People who take ENVARSUS XR have sometimes been given the wrong medicine because some medicines have the same ingredient (tacrolimus) as ENVARSUS XR. Check your ENVARSUS XR when you get a new prescription to make sure you have received the right medicine.

Call your doctor right away if you think you were given the wrong medicine.

Ask your doctor or pharmacist if you are not sure what ENVARSUS XR should look like.

High blood sugar (diabetes). Your doctor may do certain tests to check for diabetes while you take ENVARSUS XR. Call your doctor right away if you have:

frequent urination

confusion

fruity smell on your breath

increased thirst or hunger

drowsiness

nausea, vomiting, or stomach pain

blurred vision

loss of appetite

Kidney problems. Your doctor may do certain tests to check for kidney function while you take ENVARSUS XR.

Nervous system problems. Call your doctor right away if you get any of these symptoms while taking ENVARSUS XR. These could be signs of a serious nervous system problem:

confusion

numbness and tingling

vision changes

coma

headache

muscle tremors

seizures

High levels of potassium in your blood. Your doctor may do certain tests to check your potassium level while you take ENVARSUS XR.

High blood pressure. Your doctor will monitor your blood pressure while you take ENVARSUS XR.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ENVARSUS XR for a condition for which it was not prescribed. Do not give ENVARSUS XR to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about ENVARSUS XR. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ENVARSUS XR that is written for health professionals. For more information, go to www.ENVARSUSXR.com or call 1-844-Veloxis (1-844-835-6947).

Dose Converter

IMPORTANT: Suggested dose has been rounded to an amount that can be achieved with multiples of one of the 3 tablet strengths. Actual dose should be determined and adjusted for each individual patient to achieve target trough levels.

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